Optical Surface Monitoring Technology-Guided Large-Segment Radiotherapy for Breast Cancer

• Sponsor: Peking Union Medical College Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05804916
• Collaborator: (none)
• Enrollment: 556
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 9.3

Study Details

Study Description

Brief Summary

This study is a single-center,blinded, efficacious, phase III randomized clinical trial initiated by investigators. The primary objective is to investigate the use of Surface Guided Radiation Therapy (SGRT) in combination with Deep Inspiration Breath Hold (DIBH) technique for left breast cancer treatment, compared to traditional laser alignment with free breathing treatment. This approach offers superior positioning accuracy and improved heart protection without any increase in radiation or adverse reactions.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Optical Surface Monitoring Technology; Large-segment Radiotherapy	Device: Surface Guided Radiation Therapy (SGRT)	Phase 2/Phase 3

Detailed Description

This is an investigator-initiated blinded, efficacious, phase III randomized clinical trial study. The study hypothesis is that the use of Surface Guided Radiation Therapy (SGRT) in combination with the Deep Inspiration Breath Hold (DIBH) technique for left breast cancer treatment can improve positioning accuracy and heart protection without any increase in radiation or adverse reactions. The primary endpoint of this study is the accuracy of the treatment location and incidence of patient coronary events/myocardial perfusion decline.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 556 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Control group: Patients with left breast cancer treated with traditional laser alignment with a free breathing treatment Study group: Patients with left breast cancer treated with SGRT combined with the DIBH techniqueControl group: Patients with left breast cancer treated with traditional laser alignment with a free breathing treatment Study group: Patients with left breast cancer treated with SGRT combined with the DIBH technique
• Masking: None (Open Label)
• Masking Description: Open Label
• Primary Purpose: Treatment
• Official Title: A Single-center, Blinded, Efficacious, Phase III Randomized Clinical Trial Initiated by Investigators to Investigate the Use of Surface Guided Radiation Therapy (SGRT) in Combination With Deep Inspiration Breath Hold (DIBH) Technique for Left Breast Cancer Treatment, Compared to Traditional Laser Alignment With Free Breathing Treatment
• Actual Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Apr 1, 2027
• Anticipated Study Completion Date: Apr 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SGRT+DIBH group Patients with left breast cancer treated with SGRT combined with DIBH technique	Device: Surface Guided Radiation Therapy (SGRT); SGRT and DIBH those two devices could be combined together to improve the accuracy in radiation therapy position and heart protection; Other Names: Deep Inspiration Breath Hold (DIBH) technique
No Intervention: common+Free breath group Patients with left breast cancer treated with traditional laser alignment with free breathing treatment

Outcome Measures

Primary Outcome Measures

1. Accuracy of treatment location [Change from baseline to the whole treatment procedure]

   surface optical monitoring technology and simulation of surface contour registration error generated by surface optical surface error, as well as errors obtained by Cone beam CT registration. The translational errors in the left-right (x), up-down (y), front-back (z) directions, and rotational errors Rx, Ry, Rz will be measured

2. Incidence of patient coronary events/myocardial perfusion decline [3-year]

   including the cardiac enzymes, ECG and myocardial perfusion

Secondary Outcome Measures

1. Secondary efficacy indicators [3-year]

   Correlation between surface optical monitoring technology and CBCT offset values Correlation between positioning errors and dose pass rates Patient position movement within fractions

2. cardiac safety [5-year]

   cardiac injury events include myocardial enzymes, electrocardiogram, echo, etc

3. patients' quality of life [5-year]

   scale scores of EORTC-QLQ-BR23, 0-100 scores, higher scores mean a better outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients who have undergone breast-conserving surgery or modified radical mastectomy for left breast cancer;

2. Planned whole-breast ± supraclavicular region, chest wall ± supraclavicular region radiotherapy;

3. Able to perform deep inspiration breath-hold technique with breath-holding time >35s and can repeat it continuously for more than 6 times;

4. Patients who have not received neoadjuvant chemotherapy or breast reconstruction surgery;

5. No active heart disease, myocardial infarction, congestive heart failure or other cardiac diseases at baseline;

6. Patients are fully voluntary and able to sign the informed consent form 30 days before enrollment.

Exclusion Criteria:

1. Bilateral breast cancer;

2. No pathological diagnosis;

3. Remote metastasis;

4. Receiving neoadjuvant chemotherapy or breast reconstruction;

5. Have received mediastinal radiotherapy in the past;

6. Previous history of abdominal or pelvic radiotherapy;

7. Previous or secondary primary malignant tumor;

8. Serious cardiac insufficiency; Myocardial infarction or uncorrected unstable arrhythmia or uncorrected unstable angina pectoris occurred in the last 3 months; Pericardial disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100730

Sponsors and Collaborators

• Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT05804916
• Other Study ID Numbers: SGRT-BC
• First Posted: Apr 7, 2023
• Last Update Posted: Apr 7, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peking Union Medical College Hospital: breast cancer; optical surface monitoring technology; large-segment radiotherapy
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Apr 7, 2023